Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants

Not Applicable

Completed

• Conditions: Healthy Infants
• Interventions: Dietary Supplement: DHA; Dietary Supplement: combination ARA + DHA

• Registration Number: NCT03014115
• Lead Sponsor: DSM Nutritional Products, Inc.

Brief Summary

The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.

Detailed Description

This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-09
• Primary Completion: 2019-05
• Study Completion: 2019-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• singleton infants,
• parent of legal age to consent,
• willing to feed the child the assigned study formula for the treatment duration,
• parent agrees to scheduled blood draws

Exclusion Criteria

• exclusively breastfed or formula-fed beyond 6 months,
• difficulty swallowing or other congenital malformation or metabolic anomaly,
• taking omega-3 (supplemented) foods,
• mother had gestational diabetes or is Type II diabetic,
• born at <37 weeks gestational age,
• participating in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA	DHA	0% ARA +0.4% DHA in infant formula per day
combination ARA+ DHA	combination ARA + DHA	combination 0.76% ARA+ 0.4% DHA in infant formula per day

Primary Outcome Measures

Name	Time	Method
total plasma fatty acid ARA levels	6 months of supplementation	difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation

Secondary Outcome Measures

Name	Time	Method
incidence of infections	6 months of supplementation	record number, type and duration of infections
weight gain	6 months of supplementation	differences between groups in weight gain (kg/d)
length gain	6 months of supplementation	differences between groups in length gain (cm/d)
head circumference	6 months of supplementation	differences between groups in head circumference (cm/d)
dietary intake of ARA	6 months of supplementation	24 hour recall questionnaire
plasma levels of immune markers	6 months of supplementation	cytokines and T cells levels in plasma will be measured

Trial Locations

Locations (2)

Centro de Salud Aravaca; 🇪🇸 Madrid, Spain

Centro Salud Arganda del Rey; 🇪🇸 Madrid, Spain